AzTrials
AzTrials

Asphyxia NeonatorumSAVENCT04070560

Effects of Delayed Cord Clamping During Resuscitation of Newborn Near Term and Term Infants

A study testing Intact cord (≥ 180 seconds) resuscitation and Early (≤ 60 seconds) cord clamping in people with Asphyxia Neonatorum and Resuscitation, run by Lund University at 3 sites in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study evaluates resuscitation with an intact umbilical cord compared to resuscitation with the umbilical cord cut. Half of the newborn babies in need of resuscitation will be handled while having an intact umbilical cord and half will have their umbilical cord cut. Read more about this study

Who is it for?
Ages 35 to 42 weeks
Conditions the study is for
Asphyxia Neonatorum, Resuscitation
What is being tested?
Intact cord (≥ 180 seconds) resuscitation and Early (≤ 60 seconds) cord clamping
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
3 sitesSweden
Study dates
30 Sep 2019to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 42 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Pregnancy week ≥35 + 0
  • Singletons
  • Expected vaginal delivery
  • The woman / couple can adequately assimilate information about the study
  • Signed informed consent of both prospective parents

Who cannot join

  • Congenital malformation that complicates resuscitation (such as severe malformation of mouth, pharynx, respiratory system) or which causes the child not to be resuscitated due to internal structural malformations (such as more severe heart failure, diaphragm fractures, etc.)
  • The child is born via acute caesarean section after inclusion and opening of study envelope
  • placenta abruption / or damage to umbilical cord during childbirth (when circulation through an intact umbilical cord cannot be achieved after birth)

Trial locations and contacts

3 sites in 1 country.

Sweden3 sites

  • Hospital of Halland

    Halmstad, Halland County, 30185

  • Skåne University Hospital

    Malmö, Skåne County, 21428

  • Ystad hospital

    Ystad

Other trials in Sweden

About this study

Official title: SAVE (Sustained Cord Circulation Awaiting VEntilation)

This study evaluates resuscitation with an intact umbilical cord compared to resuscitation with the umbilical cord cut. Half of the newborn babies in need of resuscitation will be handled while having an intact umbilical cord and half will have their umbilical cord cut.

Read the detailed description

The routine procedure when a newborn baby is in need of resuscitation is to cut the umbilical cord and move the baby to a designated area for resuscitation, which can include stimulation, clearing the airways, administration of oxygen and/or positive pressure ventilation by bag and mask och T-piece resuscitator.

It has been suggested, and pilot studies has shown preliminary results, that keeping the umbilical cord intact while performing resuscitation may improve the babies outcome, by continued exchange of oxygen and carbon dioxide be the placenta and facilitating the neonatal pulmonary and circulatory transition.

Because of the limiting length of the umbilical cord, resuscitation with an intact cord must be performed in close proximity to the mother.

Being tested
Intact cord (≥ 180 seconds) resuscitation, Early (≤ 60 seconds) cord clamping
Keywords
umbilical cord
Medical subject headings
Asphyxia Neonatorum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intact cord (≥ 180 seconds) resuscitationProcedure or surgery

    Resuscitation performed in near proximity to the mother with umbilical cord uncut

  • Early (≤ 60 seconds) cord clampingProcedure or surgery

    Resuscitation performed at a designated area after umbilical cord is cut

Study groups in NCT04070560
Study groupRoleWhat they receive
Early (≤ 60 seconds) cord clampingActive comparatorIf the infant don't breathe, the umbilical cord is clamped (≤ 60 seconds) and cut and resuscitation will be provided at a resuscitation table Other Name: Immediate clamping
Receives: Procedure: Early (≤ 60 seconds) cord clamping
Intact cord (≥ 180 seconds) resuscitationActive comparatorIf the infant don't breathe, the umbilical cord is not clamped and cut until after 180 seconds. Initial resuscitation will be provided bedside to the mother Other Names: Late cord clamping Deferred cord clamping Optimal cord clamping
Receives: Procedure: Intact cord (≥ 180 seconds) resuscitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Apgar score

    Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes, each sub scale 0 (absent), 1, 2 (normal). Minimum 0, maximum 10. Less than 4 is a measure for severe asphyxia, less than 7 measure of mild asphyxia.

    Measured: At 5 minutes after birth

Secondary outcomes (17)

  1. Apgar score

    Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes, each sub scale 0 (absent), 1, 2 (normal). Minimum 0, maximum 10. Less than 4 is a measure for severe asphyxia, less than 7 measure of mild asphyxia.

    Measured: At 1 minute after birth

  2. Apgar score

    Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes, each sub scale 0 (absent), 1, 2 (normal). Minimum 0, maximum 10. Less than 4 is a measure for severe asphyxia, less than 7 measure of mild asphyxia.

    Measured: At 10 minute after birth

  3. Time of first cry or breathing effort

    Assessed by staff present

    Measured: Within 10 minutes after birth

  4. Time of establishing spontaneous breathing

    Assessed by staff present

    Measured: Within 10 minutes after birth

  5. Presence at one day of age

    The place of stay for newborn at one day of age

    Measured: 24 hours

  6. Need of neonatal intensive care

    Admission to neonatal intensive care unit

    Measured: 7 days

  7. Score for Neonatal Acute Physiology (SNAP-II)

    Assessed by staff at neonatal intensive care unit

    Measured: 7 days

  8. Morbidity Assessment Index for Newborns (MAIN)

    Assessed by staff at neonatal intensive care unit

    Measured: 7 days

  9. Blood glucose

    Sampled by staff at nursery of neonatal intensive care

    Measured: 4 hours after birth

  10. Breathing difficulties

    Respiratory rate > 60, grunting/shallow breathing, nostril flaring, retractions between or under the ribs) Assessed by staff at nursery of neonatal intensive care

    Measured: 1 hours after birth

  11. Breathing difficulties

    Respiratory rate > 60, grunting/shallow breathing, nostril flaring, retractions between or under the ribs) Assessed by staff at nursery of neonatal intensive care

    Measured: 6 hours after birth

  12. Mortality

    Death after birth

    Measured: One year

  13. Development

    Assessed by Ages and Stages Questionnaire (ASQ). Minimum 0, maximum 300. Consist of 30 questions answered Yes (10), Sometimes (5), Not Yet (0). Five sub scales with six questions each: Communication, Fine motor, Gross motor, Problem solving and Personal-Social. Worse outcome is considered mean minus 2 standard deviations.

    Measured: 12 months

  14. Development

    Neurocognitive assessment by Bayley-III (alternative Bayley-IV if available). Derives a developmental quotient (DQ) three main subtests; the Cognitive Scale, the Language Scale, and the Motor Scale. Is assessed by special staff and have standardized interpretations of results.

    Measured: 24 months

  15. Autism

    Screening by Modified Checklist for Autism in Toddlers (M-CHAT). 20-question test. Answers "yes" or "no". A total score of 2 and below on the first part of the M-CHAT indicate low autism risk, a total score of 3-7 indicates medium risk and prompts administration of the follow-up form. A total score of 8 or higher indicates high autism risk.

    Measured: 24 months

  16. Development

    Neurocognitive assessment by Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV). 14 subtests. The core subtests are required for the computation of the Verbal, Performance, and Full Scale intelligence quotient (IQ). Also, two other composites Processing Speed Quotient and General Language Composite.

    Quotient and Composite scores have a mean of 100 and a standard deviation of 15. Subtest scaled scores have a mean of 10 and a standard deviation of 3. For Quotient and Composite score:

    below 70 is Extremely Low, 70-79 is Borderline, 80-89 is Low Average, 90-109 is Average, 110-119 is High Average, 120-129 is Superior, 130+ is Very Superior.

    Measured: 54 months

  17. Motor development

    Assessed by Movement Assessment Battery for Children (ABC). The test contains 8 tasks covering the following 3 areas: Manual Dexterity, Ball Skills, Static and Dynamic Balance. Standard scores for each domain can be compared to normative data and interpreted in terms of percentile equivalents (a) ≤5th percentile reflecting definite motor impairment, (b) ≤15th percentile reflecting borderline motor impairment, or (c) >15th percentile reflecting no motor impairment.

    Measured: 54 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start30 Sep 2019
  3. Primary completion30 Nov 2024
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04070560
Sponsor's protocol ID
SAVE1
Acronym
SAVE
Status last verified
Mar 2025
First submitted
26 Aug 2019
Last updated
17 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in publications, after deidentification (text, tables, figures, and appendices).

Publications

  • Niermeyer S, Velaphi S. Promoting physiologic transition at birth: re-examining resuscitation and the timing of cord clamping. Semin Fetal Neonatal Med. 2013 Dec;18(6):385-92. doi: 10.1016/j.siny.2013.08.008. Epub 2013 Sep 19.

    PubMed 24055300

  • Katheria AC, Brown MK, Faksh A, Hassen KO, Rich W, Lazarus D, Steen J, Daneshmand SS, Finer NN. Delayed Cord Clamping in Newborns Born at Term at Risk for Resuscitation: A Feasibility Randomized Clinical Trial. J Pediatr. 2017 Aug;187:313-317.e1. doi: 10.1016/j.jpeds.2017.04.033. Epub 2017 May 16.

    PubMed 28526223

  • Katheria AC. Neonatal Resuscitation with an Intact Cord: Current and Ongoing Trials. Children (Basel). 2019 Apr 22;6(4):60. doi: 10.3390/children6040060.

    PubMed 31013574

  • Andersson O, Rana N, Ewald U, Malqvist M, Stripple G, Basnet O, Subedi K, Kc A. Intact cord resuscitation versus early cord clamping in the treatment of depressed newborn infants during the first 10 minutes of birth (Nepcord III) - a randomized clinical trial. Matern Health Neonatol Perinatol. 2019 Aug 29;5:15. doi: 10.1186/s40748-019-0110-z. eCollection 2019.

    PubMed 31485335

  • Ekelof K, Saether E, Santesson A, Wilander M, Patriksson K, Hesselman S, Thies-Lagergren L, Rabe H, Andersson O. A hybrid type I, multi-center randomized controlled trial to study the implementation of a method for Sustained cord circulation And VEntilation (the SAVE-method) of late preterm and term neonates: a study protocol. BMC Pregnancy Childbirth. 2022 Jul 26;22(1):593. doi: 10.1186/s12884-022-04915-5.

    PubMed 35883044

  • Wilander M, Sandblom J, Thies-Lagergren L, Andersson O, Svedenkrans J. Bilirubin Levels in Neonates >/=35 Weeks of Gestation Receiving Delayed Cord Clamping for an Extended Time-An Observational Study. J Pediatr. 2023 Jun;257:113326. doi: 10.1016/j.jpeds.2023.01.005. Epub 2023 Jan 14.

    PubMed 36646247

Questions about this trial

What is this clinical trial studying?

A study testing Intact cord (≥ 180 seconds) resuscitation and Early (≤ 60 seconds) cord clamping in people with Asphyxia Neonatorum and Resuscitation, run by Lund University at 3 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Apgar score (time frame: At 5 minutes after birth). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04070560, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in